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Machine that keeps donor livers alive could expand transplants

NCT ID NCT04194437

Disease control Sponsor: TransMedics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This trial tested a portable machine called the OCS Liver System that keeps donor livers healthy outside the body. The goal was to see if it could help more livers from donors after circulatory death be used for transplant. Only 9 people took part, and the study was stopped early, so we don't have clear answers yet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Portable Organ Care System (OCS) Liver device
What this could lead to
If successful, this device could help more donor livers be used for transplant, potentially reducing waitlist deaths.
What could go wrong
This was a very small, early trial that was terminated early, so results are limited. The device may not improve outcomes or could have safety issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Jul 2020

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Registered primary liver transplant candidate * Age ≥ 18 years * Obtained informed consent Exclusion Criteria: * Acute, fulminant liver failure * Prior solid organ or bone marrow transplant * Ventilator dependent on day of transplant/donor organ offer

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver transplant

Contacts and locations

Locations

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • University of Texas San Antonio

    San Antonio, Texas, 78249, United States

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